NMPA published Notice of Modification on Medical Device Clinical Trial Approval Procedure on April 1. The Notice allows that, once the receipt of Clinical Trial Application is received, the sponsor can initiate clinical trials after waiting 60 days, in the absence of a rejection or deficiency notice. The implied approval is implemented from the date of publication.
It significantly shortens the timeline for clinical trials, and accelerates the market introduction for medical devices and IVDs. Previously, the manufacturers had to wait for a formal approval letter from NMPA to begin their clinical research. Frequently, due to backlog of applications and shortage of the reviewing staff, the manufacturers experienced significant delays waiting for NMPA’s approval.
Highlights from the Notice:
- Before submitting Clinical Trial Application, sponsors are encouraged to contact Center for Medical Device Evaluation (CMDE).
- During 60-day period, NMPA has an opportunity to review the application for safety to assure that research subjects will not be subjected to unreasonable risk.
- If no rejection or deficiency notice are issued, CMDE will publish the application number, address of applicant, name of medical device, model number and its configuration on CMDE website: www.cmde.org.cn.
The Notice stresses the amended Medical Device Supervision and Management Regulations announced on June 25, 2018. The Regulations show the relaxation of requirements for CER and clinical trials and acceptance of overseas clinical trial data; Streamlined Innovation Approval and Priority Review can be expected.
If you need assistance in clinical trials, or assessments to determine whether your overseas clinical data meets NMPA (CFDA) acceptance criteria, we do have the methodology and service available to help you. info@ChinaMedDevice.com.
For our clinical success for CT-Linac, a recently-approved innovation device, please click HERE.
For our comments on Acceptance of Overseas Clinical Data, please click HERE.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.